FDA COVID-19 Alert: Beware of Misleading Registration Certificates

How to tell if a device is approved, cleared, or authorized by the FDA

During the COVID-19 pandemic, some companies are selling medical devices (including masks, respirators, and face shields) using misleading “FDA registration certificates.” The registration certificates usually look like official government documents, often displaying the FDA logo.

The FDA does not issue any type of registration certificates to medical device firms. Accordingly, the FDA has asked the firms that issue such registration certificates to stop issuing them.

These registration certificates may mislead consumers to believe a device was reviewed, approved, cleared, or authorized by the FDA.

Is a device FDA approved, cleared, or authorized?

In response to an increase in the use of misleading FDA registration certificates during the COVID-19 pandemic, the FDA has developed a new web resource for consumers: Are there “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved?

This page provides easy-to-follow instructions to check if the FDA has approved or cleared a device – or if the FDA authorized the device for emergency use during a public health emergency, like COVID-19.